The present invention relates generally to packaging of unit-dosage drug formulations, and more particularly in providing a limited-access blister pack that both satisfies the U.S. Poison Prevention Packaging Act regarding child-resistance, and provides a safe, sturdy, and economical package for the transport and dispensing of fast-dissolving dosage form (FDDF) drug formulations.
Recent Federal legislation has been enacted requiring manufacturers to provide child-resistant packaging. The U.S. Poison Prevention Packaging Act was enacted to safeguard uncomprehending children from pharmaceuticals that may pose a danger to them. The marketplace is full of children's formulations that are made to be palatable to them, but with the unfortunate side-effect that this predisposes children to believing that any pills or liquids in bottles will taste good, and not hurt them.
It is desirable to provide a package form that is both easy to use for adults, protective for the pharmaceutical within, and difficult for children to open. The blister pack of the present invention is easy to open for an adult, access being facilitated by entry at one or two points, with a total of four steps necessary to access the drug form within. This method of access is both obvious to an adult, yet inhibitory to a child. The material forming the blister pack is sufficiently strong such that even an adult would have great difficulty in tearing it without utilizing the prearranged scheme for tearing across the perforated, pre-weakened lines. The blister pack is sturdy enough for fragile FDDF drug forms, provides protection from physical stresses, and is also moisture resistant. These considerations are important for pharmaceuticals formed by lyophilization, or freeze-drying. The dosage form may be a capsule, tablet, or the like.
Prior-art child-resistant blister packs have never before combined the advantages present in the present invention. This invention presents a physically tough blister pack, well suited to fragile FDDF drug forms. The invention is also comprised of a water-tight lidding sheet, which must be peeled back to expose the dosage form within. Access to the fragile FDDF drug forms is inhibited to children by allowing for only single- or double-entry points on the blister pack, combined with sequential performance of a number of steps to obtain access to a single dosage form.
There is shown in the prior art various forms of blister packs, none of which embodies all of the features and advantages of the present invention. The Intini reference, U.S. Pat. No. 4,537,312, discloses a tamper-evident, three-layer blister pack, comprised of a blister layer intermediate to an upper layer that is fitted with tabs, and a lower layer with perforated segments located below said tabs on the upper layer. The tabs are provided along the edges for grasping, thereby removing the perforated protective lower layer, allowing the user to access the single dosage units by rupturing the aluminum foil that seals the dosage unit within the intermediate layer. Intini does not disclose the inventive construction and functions in a different fashion, i.e., the user is instructed to push the dosage unit of Intini through the foil, which would damage a fragile FDDF drug form as is protected by the present invention and there is no provision in Intini for limited access to the blister pack as each unit becomes immediately accessible.
Gregory et al., U.S. Pat. No. 4,305,502, relates to a blister pack for fragile freeze-dried chemical or pharmaceutical compositions. It is a two-piece composition, made of an upper plastic blister film with depressions for receiving the dosage forms, and a laminate cover sheet adhered to it. The surface of the cover sheet is scored to allow access to the dosage units within, which are formed in place by freeze-drying. The Gregory package does not provide for sufficient child-resistance, as any one of the units may be accessed by a single procedure. There are multiple entry points, unlike the present invention where there are limited entry points, and a preordained sequence must be executed in order to gain access. Also, the scores are not through the entire pack, as they are in the present invention. Margulies, U.S. Pat. No. 4,243,144, discloses a two-piece bend-and-peel blister strip package. Each dosage unit is divisible by separation along perforations. Access is provided in two steps by pushing down a lower edge strip, then grasping and peeling back the exposed unsealed upper layer. Lines of weakening guide the tearing of the upper layer. Each unit is accessible individually and immediately, unlike the present invention, wherein access is inhibited by the limited number of entry points, and the required completion of the sequential tearing. In addition, access to the unsealed regions is accomplished by different means.
Haines, U.S. Pat. No. 3,835,995, discloses a child-resistant two-piece blister pack in which access is attained in a predetermined manner. A tear strip is removed, revealing a hole in the laminate layer that is used to grasp an unsealed portion of said laminate later, thereby allowing the user to peel back the laminate exposing the dosage form. A limited number of entry points, one per side, is provided. The present invention differs from this reference in that access to the blister pack is enabled by removal of the tear strip, whereas in this reference, access to the individual dosage units is enabled. Also in Haines access is from the edge of the pack after only one preliminary step, as opposed to access after three steps in the present invention.